Leader Nighttime Cough

Product NDC: 70000-0193
Requested package NDC: 70000-0193-1
11-digit product format: 700000193
Labeler code: 70000
Product ID: 70000-0193_cefe432b-99ca-4f90-b5dd-82aa3517a062
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Cardinal Health 110, LLC. dba Leader
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-11-29
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30 mg/30mL; mg/30mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70000-0193	70000-0193-1	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0193	70000-0193-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0193	70000-0193-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0193-1	ML - Milliliter	70000-0193	337af696-68f0-4b14-a30f-96f81656cc22	1	2017-11-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0193-1	70000019301	355 mL in 1 BOTTLE (70000-0193-1)	355 ml	2016-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cardinal Health Nighttime Cough Drug Facts	Cardinal Health 110, LLC. dba Leader	2024-10-22	HUMAN OTC DRUG LABEL	5

Leader Nighttime Cough

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#